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European and International Certification for Pharmaceutical Packaging Materials. The development of an International Standard for Pharmaceutical Packaging Materials Tony Harper Principal UK Expert to ISO/TC 76 WG 6. European and International Standards. UK France Germany Sweden ISO.

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European and international certification for pharmaceutical packaging materials l.jpg
European and International Certification for Pharmaceutical Packaging Materials

The development of an International Standard for Pharmaceutical Packaging Materials

Tony Harper

Principal UK Expert to ISO/TC 76 WG 6

© 2006


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European and International Standards Packaging Materials

  • UK

  • France

  • Germany

  • Sweden

  • ISO

© 2006


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European Certification Packaging Materials

  • Certipharm – France

  • QAPP (Quality Association for Pharmaceutical Packaging) – Germany

  • PQG (Pharmaceutical Quality Group) – UK

  • Sweden

  • International Certification Bodies

    • AJA, BSI, BVQI, DNV, LRQA, NQA, NSAI, SGS-Y, TUV & more to come?

© 2006


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European Certification Packaging Materials

  • Standards

  • Auditors

  • Training

  • Certification

  • Co-operation

  • Recognition

  • Harmonisation.

© 2006


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European Certification Packaging Materials

  • France, Germany and UK

    • Meetings

    • Comparison of standards

    • Comparison of auditing

    • Witnessed audits, two in each country planned

    • Evaluation

    • Process for recognition to be defined and then work towards harmonisation of standards, auditor training, auditing and certification

    • Other interested parties & countries welcome!

    • Please volunteer – particularly to work on ISO 15378!!

© 2006


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Auditor Certification Packaging Materials

  • Standards in Europe are similar

  • Standard of auditing varies

  • Need to harmonise

  • Use PQG Auditor Scheme as a basis?

  • Extend to Europe??

  • Extend Worldwide???

© 2006


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UK Standards Packaging Materials

  • Codes of Practice – 1990 - 2001

    • P00020 Raw Materials

    • P00021 Printed Components

    • P00022 Contact Packaging

  • PS 9000:2001 - >>>>>

    • Contact & Packaging in one Standard

  • PS 9004:2004

    • Guide to the GMP requirements of PS 9000.

© 2006


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French Standards Packaging Materials

  • Certipharm

    • GMP requirements for suppliers

    • Reading Guide

    • French translation of PS 9000!

© 2006


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German Standards Packaging Materials

  • Quality Association Pharmaceutical Packaging – QAPP

    • Membership of QAPP mandatory for Certification

    • Secondary Packaging Material Suppliers only

    • QAPP GMP Standard

    • Good level of validation.

© 2006


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Sweden Packaging Materials

  • PS 9000

    • Translated into Swedish

      • Cerbo – Primary (Trollhattan) & Secondary Packaging Materials (Gothenburg)

      • Nord-Emballage & Zata – Secondary Packaging Materials only (2 sites in Ystad).

© 2006


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International Standards Packaging Materials

  • ISO 15378:2006

    • Includes all of ISO 9001:2000

    • Additional requirements for packaging materials

    • 2006 version – primary packaging only

    • Mandatory Annex for Printed Components

    • Guidance Annexes for Risk management and Validation.

© 2006


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Development process Packaging Materials

  • Initial German ‘ad-hoc’ meeting, 2002

  • Ad-hoc group within ISO/TC 76, 2003

  • Initial drafts, limited circulation, 2003-4

  • UK involvement, suggested significant changes, 2003-2005

  • Ad-hoc group became ISO/TC 76 WG 6

  • NWI – ISO New Work Item: ISO 15378.

© 2006


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ISO/TC 76 Packaging Materials

  • “Infusion, transfusion and medical equipment”!

    • Not the ideal ‘home’

    • Limited contacts (internationally)

    • Drafts did not reach the people who could comment

    • Input limited to the ‘few’

    • Composition of WG 6 was unbalanced.

© 2006


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UK Input Packaging Materials

  • UK Team

    • Tony Harper

    • Roy Evans

    • Jill Jenkins

    • Steve Taylor

    • Ashok Chand

    • David Abraham

    • Antoinette Devine

    • Bill Hewlett

    • Mike Shorten

    • John Turner ….. and others - maybe some of you!

© 2006


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What did UK do! Packaging Materials

  • Ensured a more consistent approach

  • Removed many errors

  • Identified omissions

  • Made significant additions based on PS 9000

  • Turned the draft into an auditable document

  • Assisted the Secretariat with editing.

© 2006


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The result! Packaging Materials

© 2006


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© 2006 Packaging Materials


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© 2006 Packaging Materials


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ISO 15378 – Key Requirements Packaging Materials

  • 4.2.4 Records

  • 5.5.3 Internal communication

  • 6.2.2.1 GMP Training

  • 6.4 Work environment

  • 6.5 Maintenance

  • 7.2.3 Customer communication

  • 7.4.1 Purchasing

  • 7.5 Cleanliness & contamination control

  • 8.2.4.1 OOS (Out of Specification)

  • 8.3 Non-conforming product.

© 2006


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The (2) key annexes Packaging Materials

  • Annex B – Validation

  • Annex C – Risk Management

  • These two annexes although ‘Normative’, i.e. guidance, are probably the most significant additions to PS 9000 and were developed by an International team.

© 2006


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ISO 15378:2006 Packaging Materials

  • Publication expected 31/03/06

  • Certification will follow

  • Glass companies expected to lead the way – Internationally

  • ‘Others’ will follow

  • What will PQG do to promote and encourage?

© 2006


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What next? Packaging Materials

  • Extend the scope for Secondary Packaging Materials

  • Produce a supporting Guidance document

  • And how do these fit in? >>>>>>>>>>>

© 2006


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ISO 9001 Packaging Materials

Scope

GMP (GxP) Principles

Detail & Auditor competence

ISO 9001 + GMP

=

ISO 15378

GMP

Guidance


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ISO 9000 Packaging Materials

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Primary

Packaging materials

Inhalation


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Any questions please? Packaging Materials

TonyHarper@aol.com

© 2006